Genmab reports Phase 1/2 RAINFOL-01 data showing rinatabart sesutecan (Rina-S) plus bevacizumab demonstrated manageable safety with no new signals in recurrent ovarian cancer.
Written By: Karthik Teja Macharla, PharmD
Reviewed By: Pharmacally Editorial Team
Genmab reported new clinical data showing that the investigational antibody-drug conjugate rinatabart sesutecan (Rina-S) combined with bevacizumab demonstrated a tolerable and manageable safety profile in patients with recurrent ovarian cancer. The results come from cohort D2 of the Phase 1/2 RAINFOL-01 study, presented at the 2026 Society of Gynecologic Oncology Annual Meeting.
Study Design and Treatment Regimen
Rina-S is a folate receptor alpha (FRα)-targeted antibody-drug conjugate delivering a topoisomerase I inhibitor payload. The study evaluated Rina-S administered at 120 mg/m² plus bevacizumab every three weeks until disease progression or unacceptable toxicity. The primary endpoint was safety and tolerability.
Safety Results from Combination Cohort
At data cutoff, 40 patients with recurrent ovarian cancer received the combination. The regimen was tolerable, and adverse events were consistent with the known safety profiles of the individual agents. No new or unexpected safety signals were observed. The most common treatment-emergent adverse events occurring in at least 25% of patients were nausea (80%), fatigue (67.5%), anemia (55%), and neutropenia (45%). Serious adverse events were reported in six patients (15%), while dose reductions occurred in 27.5% of patients. Treatment discontinuation occurred in two patients, and no fatal adverse events were reported. Notably, investigators did not observe ocular toxicity, peripheral neuropathy, interstitial lung disease, or clinically significant bleeding.
Investigator Perspective on Clinical Relevance
Study investigator Dr. Cara Mathews stated that advanced ovarian cancer remains difficult to treat and emphasized that demonstrating safe combination use with bevacizumab could expand treatment options and help manage resistance. She also noted that Rina-S previously showed manageable safety as monotherapy, and the new findings suggest the combination does not meaningfully increase toxicity.
Company View on Development Path
Genmab’s Chief Medical Officer Tahamtan Ahmadi said the safety findings strengthen the clinical foundation for Rina-S and support further development in combination regimens. He added that the therapy could expand treatment possibilities across gynecologic cancers as it advances into late-stage development.
Broad Late-Stage Clinical Program
Rina-S is currently being evaluated across a broad clinical program. Ongoing studies include the Phase 1/2 RAINFOL-01 trial (NCT05579366), the Phase 3 RAINFOL-02 trial in platinum-resistant ovarian cancer, the Phase 3 RAINFOL-03 study in recurrent or progressive endometrial cancer, and the Phase 3 RAINFOL-04 maintenance trial in platinum-sensitive ovarian cancer. The agent is also being investigated in the Phase 2 RAINFOL-05 study in non-small cell lung cancer.
RAINFOL-01 Trial Overview
RAINFOL-01 is an open-label, multicenter Phase 1/2 study evaluating Rina-S administered every three weeks at different dose levels in FRα-expressing solid tumors. The trial includes multiple parts, with Part D assessing combination therapy cohorts such as Rina-S plus bevacizumab.
Ovarian cancer remains a major global health burden, with more than 320,000 new cases diagnosed annually worldwide. Most patients present with advanced disease, and recurrence occurs in approximately 70–90% of women following initial treatment. Five-year survival rates typically range between 30% and 50%, highlighting the need for new therapeutic strategies.
Rina-S (GEN1184) consists of a human monoclonal antibody targeting FRα, linked via a protease-cleavable linker to the topoisomerase I inhibitor exatecan. The therapy remains investigational, and its safety and efficacy have not yet been established.
Reference
Genmab Presents the Safety and Tolerability of Rinatabart Sesutecan (Rina-S®) in Combination with Bevacizumab in Advanced Ovarian Cancer – Genmab A/S Genmab Presents the Safety and Tolerability of Rinatabart Sesutecan (Rina-S®) in Combination with Bevacizumab in Advanced Ovarian Cancer – Genmab A/S 13 April 2026.
About the Writer
Karthik Teja Macharla, PharmD is a Pharm.D. graduate with a strong interest in clinical research, pharmacovigilance, and medical writing. In his words, he is passionate about converting complex medical information into clear, evidence-based scientific communication, committed to contributing to patient safety and advancing healthcare through accurate and impactful medical content.